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Ischemic Attack, TransientPhase 3POINTNCT00991029

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial

A Phase 3 study testing Clopidogrel in people with Ischemic Attack, Transient, run by University of California, San Francisco at 210 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Attack, Transient
What is being tested?
Clopidogrel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,881 participants
Where
210 sitesin 10 countries
Study dates
28 May 2010to 9 Apr 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Neurological deficit (based on history or exam) attributed to focal brain ischemia and EITHER:
  • High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score of (greater than or equal to) 4 OR
  • Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3 at the time of randomization
  • Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
  • Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
  • Ability to tolerate aspirin at a does of 50-325 mg/day.

Who cannot join

  • Age <18 years
  • TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
  • In the judgment of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.
  • Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
  • Gastrointestinal bleed or major surgery within 3 months prior to index event.
  • History of nontraumatic intracranial hemorrhage.
Show all 23Show fewer
  • Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
  • Qualifying ischemic event induced by angiography or surgery.
  • Severe non-cardiovascular comorbidity with life expectancy <3 months.
  • Contraindication to clopidogrel or aspirin.
  • Known allergy
  • Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency (prior or concurrent diagnosis, with International Normalized Ratio (INR)>1.5 or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
  • Hemostatic disorder or systemic bleeding in the past 3 months
  • Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia (<1 x10^9/l)
  • History of drug-induced hematologic or hepatic abnormalities
  • Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).
  • Inability to swallow medications.
  • At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
  • Unavailability for follow-up.
  • Signed and dated informed consent not obtained from patient.
  • Other neurological conditions that would complicate assessment of outcomes during follow-up.
  • Ongoing treatment in another study of an investigational therapy that may potentially interact with study drug, or treatment in such a study within the last 7 days.
  • Previously enrolled in the POINT study.

Trial locations and contacts

210 sites in 10 countries.

210 sites in 10 countries

United States147 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Summa Akron City Hospital

    Akron, Ohio, 44304

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University Medical Center Brackenridge

    Austin, Texas, 78701

  • Seton Medical Center

    Austin, Texas, 78705

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Kings County Hospital Center

    Brooklyn, New York, 11203

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina, 29425

  • UVA Medical Center

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois Hospital

    Chicago, Illinois, 60612

  • Mercy Health West Hospital

    Cincinnati, Ohio, 45211

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Jewish Hospital

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Palmetto Health Richland

    Columbia, South Carolina, 29203

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Texas Health Presbyterian Hospital - Dallas

    Dallas, Texas, 75231

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • Harper University Hospital

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Sinai-Grace Hospital

    Detroit, Michigan, 48235

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • St. Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • JFK Medical Center

    Edison, New Jersey, 08820

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Evanston Hospital

    Evanston, Illinois, 60201

  • St. Elizabeth Hospital

    Florence, Kentucky, 41042

  • St. Elizabeth Hospital Fort Thomas

    Fort Thomas, Kentucky, 41075

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • UF Health Shands Hospital

    Gainesville, Florida, 32608

  • NorthShore Glenbrook Hospital

    Glenview, Illinois, 60026

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Benefis Hospitals Inc

    Great Falls, Montana, 59405

  • Great Falls Clinic Hospital, Great Falls

    Great Falls, Montana, 59405

  • Guilford Neurologic Associates

    Greensboro, North Carolina, 27405

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Valley Baptist Medical Center - Harlingen

    Harlingen, Texas, 78550

  • Pennsylvania State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • the Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Florida

    Jacksonville, Florida, 32209

  • Presence Saint Joseph Medical Center

    Joliet, Illinois, 60435

  • University of Kansas Hospital

    Kansas City, Kansas, 66160

  • UCSD Health La Jolla

    La Jolla, California, 92037

  • St. Anthony Hospital

    Lakewood, Colorado, 80228

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • University of Minnesota Medical Center Hospital

    Minneapolis, Minnesota, 55454

  • WVU Healthcare Ruby Memorial Hospital

    Morgantown, West Virginia, 26505

  • Vanderbilt University Hospital

    Nashville, Tennessee, 37323

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • New York Presbyterian / Columbia University Medical Center

    New York, New York, 10032

  • NYP Weill Cornell Medical Center

    New York, New York, 10065

  • Christiana Hospital

    Newark, Delaware, 19713

  • Desert Regional Medical Center

    Palm Springs, California, 92262

  • Huntington Memorial Hospital

    Pasadena, California, 91105

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Oregon Health and Science University Hospital

    Portland, Oregon, 97239

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Bon Secours St. Francis Medical Center

    Richmond, Virginia, 23114

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

  • Henrico Doctors' Hospital - Forest Campus

    Richmond, Virginia, 23229

  • Henrico Doctors' Hospital - Parham Campus

    Richmond, Virginia, 23294

  • Mayo Clinic Saint Mary's Campus

    Rochester, Minnesota, 55902

  • Rochester General Hospital

    Rochester, New York, 14621

  • Strong Memorial Hospital

    Rochester, New York, 14642

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • United Hospital

    Saint Paul, Minnesota, 55102

  • University of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • Scripps Mercy Hospital San Diego

    San Diego, California, 92103

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California, 92103

  • San Francisco General Hospital

    San Francisco, California, 94110

  • UCSF Medical Center

    San Francisco, California, 94143

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Harborview Medical Center

    Seattle, Washington, 98104

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Southern Illinois University Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital

    Springfield, Missouri, 65804

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Mercy Hospital

    St Louis, Missouri, 63141

  • Stanford University Medical Center

    Stanford, California, 94305

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Lincoln Medical and Mental Health Center

    The Bronx, New York, 10451

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • William Beaumont Hospital - Troy

    Troy, Michigan, 48085

  • Banner University Medical Center - Tucson Campus

    Tucson, Arizona, 85724

  • George Washington University Hospital

    Washington D.C., District of Columbia, 20037

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • UMASS Memorial Medical Center

    Worcester, Massachusetts, 01655

  • WellSpan York Hospital

    York, Pennsylvania, 17403

Other trials in United States

Germany12 sites

  • Neurological Clinic Bad Neustadt

    Bad Neustadt an der Saale

  • Vivantes Hospital Neukolln

    Berlin

  • Central Bremen Hospital

    Bremen

  • University Hospital Essen

    Essen

  • University Hospital Frankfurt

    Frankfurt

  • University Medical Center Hamburg

    Hamburg

  • Hannover Medical School

    Hanover

  • University Hospital Heidelberg

    Heidelberg

  • University Hospital Schleswig-Holstein Kiel Campus

    Kiel

  • University Medical Center Leipzig

    Leipzig

  • University Hospital Munster

    Münster

  • University Hospital of Ulm

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

United Kingdom10 sites

  • Addenbrooke's Hospital

    Cambridge

  • Queen Elizabeth University Hospital

    Glasgow

  • Northwick Park Hospital

    Harrow

  • The Royal London Hospital

    London

  • University College Hospital

    London

  • Luton and Dunstable University Hospital

    Luton

  • John Radcliffe Hospital

    Oxford

  • Royal United Hospital - Bath

    Somerset

  • Southampton General Hospital

    Southampton

  • Royal Stoke University Hospital

    Stoke-on-Trent

Other trials in United Kingdom

Australia9 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Box Hill Hospital

    Box Hill, Victoria

  • Monash Medical Centre

    Clayton, Victoria

  • The Northern Hospital

    Epping, Victoria

  • Footscray Hospital

    Footscray, Victoria

  • Gosford Hospital

    Gosford, New South Wales

  • Austin Hospital

    Heidelberg, Victoria

  • John Hunter Hospital

    New Lambton, New South Wales

  • Royal Melbourne Hospital

    Parkville, Victoria

Other trials in Australia

Canada9 sites

  • University of Calgary - Foothills Campus

    Calgary, Alberta

  • Grey Nuns Hospital

    Edmonton, Alberta

  • University of Alberta Hospital

    Edmonton, Alberta

  • Charles LeMoyne Hospital

    Greenfield Park, Quebec

  • London Health Sciences Center

    London, Ontario

  • Montreal General Hospital

    Montreal, Quebec

  • Notre-Dame Hospital

    Montreal, Quebec

  • Enfant-Jesus Hospital

    Québec

  • Vancouver General Hospital

    Vancouver, British Columbia

Other trials in Canada

Spain9 sites

  • Hospital del Mar

    Barcelona

  • Santa Creu and Sant Pau Hospital

    Barcelona

  • Vall d'Hebron Hospital

    Barcelona

  • Basurto Hospital

    Bilbao

  • Burgos University Hospital

    Burgos

  • Hospital Donostia

    Donostia / San Sebastian

  • Girona University HOspital

    Girona

  • La Fe University Hospital

    Valencia

  • Miguel Servet Hospital

    Zaragoza

Other trials in Spain

France6 sites

  • Fleyriat Hospital

    Bourg-en-Bresse

  • Pierre Wetheimer Hospital

    Bron

  • Adolphe de Rothschild Ophthalmologic Foundation

    Paris

  • Bichat-Claude Bernard Hospital

    Paris

  • Pitie-Salpetriere Hospital

    Paris

  • Foch Hospital

    Suresnes

Other trials in France

Mexico5 sites

  • Culiacan General Hospital

    Culiacán, Sinaloa

  • Neurosciences Clinical Trials

    Culiacán, Sinaloa

  • ABC Medical Center Santa Fe

    Mexico City

  • Mexican Association for Clinical Research

    Pachuca, Hidalgo

  • Central Hospital Dr. Ignacio Morones Prieto

    San Luis Potosí City, San Luis Potosí, 78240

Other trials in Mexico

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki

  • Turku University Hospital

    Turku

Other trials in Finland

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

Read the detailed description

Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, is a prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel (600 mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12 hours of time last known free of new ischemic symptoms.

Its primary objective is to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day (with a dose of 150-200 mg daily for 5 days followed by 75-100 mg daily strongly recommended).

Patients over 18 years of age with high-risk TIA (defined as an ABCD2 score greater than or equal to 4) or minor ischemic stroke (with NIHSS less than or equal to 3) who can be treated within 12 hours of time last known free of new ischemic symptoms will be enrolled.

Subjects will be randomized 1:1 (clopidogrel: placebo), controlling for clinical center. A study participant's eligibility will be determined by site personnel prior to accessing the Randomization Module in the WebDCU™, a web-enabled clinical trials management system that was developed by the NETT Statistics and Data Management Center (SDMC) at Medical University of South Carolina (MUSC).Qualified users will access the Randomization Interface and complete a protocol-specific eligibility checklist. If the Randomization Interface finds the patient to be eligible based on the information provided, a randomization number and a confirmatory e-mail are generated.

Each subject is followed for 90 days from randomization; the trial will be completed in 7 years.

A total of 5,840 patients will be recruited. Recruitment will occur over 90 months, with a goal rate of 0.40 subjects/site/month for US sites, and a goal rate of 0.47 subjects/site/month for OUS sites. Current participating sites can be found at: http://www.pointtrial.org/node/18.

Being tested
Clopidogrel, placebo
Keywords
Transient Ischemic Attack, TIA, minor stroke
Medical subject headings
Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClopidogrelDrug

    Also called Plavix

    Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days

  • placeboDrug

    Loading dose of 8 tablets followed by one tablet daily for 89 days

Study groups in NCT00991029
Study groupRoleWhat they receive
clopidogrelActive comparatorPatients assigned to clopidogrel in addition to aspirin
Receives: Drug: Clopidogrel
placeboPlacebo comparatorPatients assigned to placebo in addition to aspirin
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes

    Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes

    Measured: Up to 90 days

  2. Major Hemorrhage

    Primary safety outcome: Number of Participants with major hemorrhage

    Measured: Up to 90 days

Secondary outcomes (5)

  1. Ischemic Stroke

    Secondary efficacy outcome:Number of participants with Ischemic stroke

    Measured: Up to 90 days

  2. Myocardial Infarction

    Secondary efficacy outcome: Number of participants with Myocardial infarction

    Measured: Up to 90 days

  3. Death From Ischemic Vascular Causes

    Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes

    Measured: Up to 90 days

  4. Ischemic or Hemorrhagic Stroke

    Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke

    Measured: Up to 90 days

  5. Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage

    Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage

    Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2009 (estimated)
  2. Study start28 May 2010
  3. Primary completion9 Apr 2018
  4. Study completion9 Apr 2018

Why it stopped: The trial was halted by the DSMB.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00991029
Sponsor's protocol ID
1U01S062835-01A1
Acronym
POINT
Status last verified
Nov 2018
First submitted
6 Oct 2009
Last updated
4 Dec 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ovbiagele B. Antiplatelet therapy in management of transient ischemic attack: overview and evidence-based rationale. J Emerg Med. 2008 May;34(4):389-96. doi: 10.1016/j.jemermed.2007.08.056. Epub 2008 Jan 18.

    PubMed 18207691

  • Giles MF, Rothwell PM. Risk of stroke early after transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2007 Dec;6(12):1063-72. doi: 10.1016/S1474-4422(07)70274-0. Epub 2007 Nov 13.

    PubMed 17993293

  • Kernan WN, Schindler JL. Rapid intervention for TIA: a new standard emerges. Lancet Neurol. 2007 Nov;6(11):940-1. doi: 10.1016/S1474-4422(07)70249-1. No abstract available.

    PubMed 17928271

  • Rothwell PM. Transient ischaemic attacks: time to wake up. Heart. 2007 Aug;93(8):893-4. doi: 10.1136/hrt.2007.121111.

    PubMed 17639101

  • Streifler JY. Early stroke risk after a transient ischemic attack: can it be minimized? Stroke. 2008 Jun;39(6):1655-6. doi: 10.1161/STROKEAHA.107.510248. Epub 2008 Mar 27. No abstract available.

    PubMed 18369165

  • Dean N, Shuaib A. Transient ischaemic attacks: unstable, treatable, neglected. Lancet. 2007 Oct 20;370(9596):1398-400. doi: 10.1016/S0140-6736(07)61449-4. No abstract available.

    PubMed 17928045

  • Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.

    PubMed 17931979

  • Geisler T, Zurn C, Paterok M, Gohring-Frischholz K, Bigalke B, Stellos K, Seizer P, Kraemer BF, Dippon J, May AE, Herdeg C, Gawaz M. Statins do not adversely affect post-interventional residual platelet aggregation and outcomes in patients undergoing coronary stenting treated by dual antiplatelet therapy. Eur Heart J. 2008 Jul;29(13):1635-43. doi: 10.1093/eurheartj/ehn212. Epub 2008 May 24.

    PubMed 18503057

  • Lotfi A, Schweiger MJ, Giugliano GR, Murphy SA, Cannon CP; TIMI 22 Investigators. High-dose atorvastatin does not negatively influence clinical outcomes among clopidogrel treated acute coronary syndrome patients--a Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) analysis. Am Heart J. 2008 May;155(5):954-8. doi: 10.1016/j.ahj.2007.12.009. Epub 2008 Feb 19.

    PubMed 18440347

  • Mitsios JV, Papathanasiou AI, Rodis FI, Elisaf M, Goudevenos JA, Tselepis AD. Atorvastatin does not affect the antiplatelet potency of clopidogrel when it is administered concomitantly for 5 weeks in patients with acute coronary syndromes. Circulation. 2004 Mar 23;109(11):1335-8. doi: 10.1161/01.CIR.0000124581.18191.15. Epub 2004 Mar 15.

    PubMed 15023882

  • Riondino S, Petrini N, Donato L, Torromeo C, Tanzilli G, Pulcinelli FM, Barilla F. Effects of rosuvastatin on platelet inhibition by clopidogrel in cardiovascular patients. J Thromb Thrombolysis. 2009 Aug;28(2):151-5. doi: 10.1007/s11239-008-0254-6. Epub 2008 Jul 18.

    PubMed 18636229

  • Saw J, Brennan DM, Steinhubl SR, Bhatt DL, Mak KH, Fox K, Topol EJ; CHARISMA Investigators. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007 Jul 24;50(4):291-5. doi: 10.1016/j.jacc.2007.01.097. Epub 2007 Jul 10.

    PubMed 17659194

  • Saw J, Steinhubl SR, Berger PB, Kereiakes DJ, Serebruany VL, Brennan D, Topol EJ; Clopidogrel for the Reduction of Events During Observation Investigators. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003 Aug 26;108(8):921-4. doi: 10.1161/01.CIR.0000088780.57432.43. Epub 2003 Aug 18.

    PubMed 12925453

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clopidogrel in people with Ischemic Attack, Transient, run by University of California, San Francisco at 210 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, Germany, United Kingdom, Australia, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes (time frame: Up to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00991029, which also lists 63 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.

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